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Clinical Interest of the TcPO2 Technique (CINEYSOFT)

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ClinicalTrials.gov Identifier: NCT01808989
Recruitment Status : Recruiting
First Posted : March 12, 2013
Last Update Posted : June 14, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Brief Summary:

The measurement of the transcutaneous oxygen pressure records simultaneously the tcpO2 at the buttocks and chest level during walking. Before and after exercise the diagnosis, investigations and treatments ongoing or to be performed are recorded.

The present study focuses on the clinical interest of the transcutaneous oxygen pressure during exercise in the diagnosis of claudication in patient referred for an oximetry exercise test.


Condition or disease Intervention/treatment
Claudication Other: Exercise oxymetry

Detailed Description:

Pre-test diagnostic hypothesis with probability will be completed by the physician.

Pre-test and post test ongoing or scheduled treatments will be completed by the physician.After the test, the same post test items will be evaluated.

Analysis will be done on differences of pre and post test results.


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Study Type : Observational
Estimated Enrollment : 3500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicentric Study of the Clinical Interest of the TcPO2 Technique
Actual Study Start Date : November 2013
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020



Primary Outcome Measures :
  1. The percentage of patients for whom results tcpO2 effort led to changes in diagnosis measured by the questionnaire filled by the doctor in charge of the patient before and after the test [ Time Frame: up to 1 day ]
    during a walk on a treadmill, there is a DROP of tcpo2<-15



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with buttock pain and referred for an oximetry exercise test
Criteria

Inclusion Criteria:

  • referred for an oximetry exercise test
  • Patient able to walk on a treadmill
  • Patient covered by the French health insurance
  • Patient able to understand the protocol
  • Patient agrees to be involve in the protocol and sign the consent form

Exclusion Criteria:

  • any heart issues during the last 3 months
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01808989


Contacts
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Contact: Pierre ABRAHAM, MD; Ph.D 33-(0)-2-41-35-36-10 PiAbraham@chu-angers.fr
Contact: Isabelle DURAND ZALESKI, MD; Ph.D 33-(0)-1-40-27-41-43 isabelle.durandzaleski@hmn.aphp.fr

Locations
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France
University Hospital Recruiting
Angers, France, 49933
Contact: Pierre ABRAHAM, MD, Ph.D    33-(0)-2-41--35-36-10    PiAbraham@chu-angers.fr   
Contact: Isabelle DURAND ZALESKI, MD, Ph.D    33-(0)-40-27-41-43    isabelle.durandzaleski@hmn.aphp.fr   
Principal Investigator: Pierre ABRAHAM, MD, Ph.D         
Sub-Investigator: Isabelle DURAND ZALESKI, MD, Ph.D         
University Hospital Recruiting
Lille, France
Contact: Christophe LAMOTTE, MD         
Sub-Investigator: Christophe LAMOTTE         
University Hospital Recruiting
Lomme, France
Contact: Jacques CHEVALIER         
Sub-Investigator: Jacques CHEVALIER         
Sub-Investigator: Remi LAURENT         
University Hospital Recruiting
Marseille, France
Contact: Gabrielle SARLON         
Sub-Investigator: Gabrielle SARLON, MD         
University Hospital Recruiting
Nantes, France
Contact: Marc Antoine PISTORIUS         
Sub-Investigator: Marc Antoine PISTORIUS         
Sub-Investigator: Nicolas BREBION         
University Hospital Recruiting
Rennes, France
Contact: Guillaume MAHE, MD         
Sub-Investigator: Guillaume MAHE, MD         
University Hospital Recruiting
Toulouse, France
Contact: Alessandra Bura Riviere, MD PhD         
Sub-Investigator: Alessandra BURA RIVIERE, MD PhD         
Hospital Recruiting
Tours, France
Contact: Marion Aubourg, MD         
Sub-Investigator: Marion Aubourg, MD         
Sponsors and Collaborators
University Hospital, Angers
Investigators
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Principal Investigator: Pierre Abraham, MD; PhD University hospital, Angers, FRANCE

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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT01808989     History of Changes
Other Study ID Numbers: 2013-A00013-42
First Posted: March 12, 2013    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: June 2018

Keywords provided by University Hospital, Angers:
peripheral artery disease
tcpo2
treadmill walking test
intermittent claudication

Additional relevant MeSH terms:
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Intermittent Claudication
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms